UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017563
Receipt number R000020341
Scientific Title Intensity-modulated radiation therapy for total body irradiation in hematopoietic stem cell transplantation: Phase II study
Date of disclosure of the study information 2015/05/14
Last modified on 2021/11/17 09:07:47

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Basic information

Public title

Intensity-modulated radiation therapy for total body irradiation in hematopoietic stem cell transplantation: Phase II study

Acronym

IMRT-TBI study

Scientific Title

Intensity-modulated radiation therapy for total body irradiation in hematopoietic stem cell transplantation: Phase II study

Scientific Title:Acronym

IMRT-TBI study

Region

Japan


Condition

Condition

hematopoietic malignancy

Classification by specialty

Hematology and clinical oncology Pediatrics Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess safety and efficacy of total body irradiation by intensity-modulated radiation therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Frequency of grade 3 or worse adverse events, based on CTCAE ver. 4.0, from 3 months to 1 year after total body irradiation.

Key secondary outcomes

Reccurence-free survial, overall survival, graft survival rate, time to graft survival, and frequency of grade 3 or worse adverse events in full observation period.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

In our institution, total body irradiation are performed as preparative regimen for hematopoietic stem cell transplantation by intensity-modulated radiation therapy.
Prescribed dose is 12 Gy in 6 fractions in 3 days. Dose to lung is reduced under 10 Gy.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Undergoing hematopoietic stem cell transplantation by myeloablative preparation.
Performance status is from 0 to 2.
With informed consent. If the patient is underage, we obtain informed consent from parent or legal representation.

Key exclusion criteria

With serious complication.
With simultaneous double cancer or heterochronic double cancer in last 5 years.
With previous history of radiation.
Not being able to remain at rest during treatment.
With technical problem for intensity-modulated radiation therapy.
Being in pregnancy.
Judging inadequate by any medical, psychological or other reasons.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Hideomi
Middle name
Last name YAMASHITA

Organization

The University of Tokyo Hospital

Division name

The department of Radiology

Zip code

113-8655

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

+81-3-5800-8667

Email

yamachan07291973@yahoo.co.jp


Public contact

Name of contact person

1st name Ryosuke
Middle name
Last name TAKENAKA

Organization

The University of Tokyo Hospital

Division name

The department of Radiology

Zip code

113-8655

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

+81-3-5800-8667

Homepage URL


Email

rtakenaka-tky@umin.ac.jp


Sponsor or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The University of Tokyo Hospital

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

Tel

03-5800-5411

Email

IRBjimu-tokyo@umin.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

東京大学医学部附属病院(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 14 Day


Related information

URL releasing protocol

http://www.u-tokyo-rad.jp/data/IMRT-TBIprotocol.pdf

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

50

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 05 Month 13 Day

Date of IRB

2015 Year 05 Month 13 Day

Anticipated trial start date

2015 Year 05 Month 13 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 03 Month 31 Day

Date trial data considered complete

2021 Year 03 Month 31 Day

Date analysis concluded

2021 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 05 Month 14 Day

Last modified on

2021 Year 11 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020341


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name